1. Field of the Invention
This invention relates to a sponge device and more particularly to an ovoid, cylindrical or egg-shaped like barrier device configured for ease of insertion, anatomical fit, and removal, and having predetermined quantities of spermicides, hormones, anti-virals, anti-oxidants, anti-fungals, anti-infectives, anti-neoplastic agents, steroids, surfactants and lubricants placed within the device.
2. Background of the Invention
It is well known that in recent years there has been a steady increase in the number of sexually transmitted diseases (STD) and unwanted pregnancies throughout the world. In an effort to stem the rise of these unwanted pregnancies, many types of contraceptive devices are being utilized. Oral contraceptives and intrauterine devices (IUD) are two very popular contraceptive methods. However, not all women are capable of using oral contraceptives, and IUDs produce numerous documented side effects. Other types of contraceptives, including barrier contraceptives, have gained in popularity due to the rise of STDs. Popular barrier contraceptives include condoms, diaphragms, sponges, cervical caps, spermicidal creams, foams, foaming tablets, films and melting suppositories. The diaphragm or cervical cap must be fitted by trained medical personnel, whereas condoms may require the participation of the partner. Foams, jellies, tablets and suppositories are often messy to use, and frequently cause irritation to the user and/or partner.
Developments in contraceptive methods allow a barrier, such as a sponge or sponge device, to be impregnated with a spermicide and various other agents. The impregnated barrier not only physically prevents the passage of sperm or STDs but also chemically destroys (kills) the sperm or infective agents associated with many STDs. This represents a spermicidal impediment by physical contact, which allows a single impregnated sponge device to continue to destroy sperm throughout repeated sexual encounters--up to twenty-four (24) hour period of time.
Prior art as provided to the movant, has employed as described in U.S. Pat. No. 4,393,871, gradual release of spermicide from a sponge device can be achieved by placing the spermicide into the pre-polymer material during the polymerization of the sponge device. The spermicide/surfactant is thereby molded to form the polyurethane sponge device. In order to activate the sponge device of U.S. Pat. No. 4,393,871, tap water must be added at the site. Too large an amount of water can unduly dilute the spermicide(s), possibly rendering it ineffective. Further, tap water at the site may he contaminated, or may contain chlorine which could possibly interfere with the spermicide or cause infection.
Conversely, too small an amount of water can cause a strong presence of the spermicide leading to irritation and/or allergic reaction as described in U.S. Pat. No. 4,693,705. As outlined in U.S. Pat. No. 4,693,705, recent advances suggest a more controlled concentration of spermicide. Accordingly, it is advantageous that the spermicide be placed already in solution within the sponge and at controlled concentration such that the spermicide is active and ready to use at the site. Mixing with tap water is therefore not required.
Impregnating a sponge with a solution such that it is ready to use at the site presents many advantages over the patents described above. However, the soaked sponge device must maintain its shape as a physical barrier while packaged and during insertion. Further, it must also withstand shear forces during placement and subsequent removal. Current sponges which use a single string placed through only a portion of the sponge material can pull through the sponge upon removal. Examples of sponges which use only a small portion of their geometry for receiving a string or tied loop are described in U.S. Pat. Nos. 4,186,742; 4,309,997; and 4,693,705. Another exemplary attachment scheme showing a loop affixed to the outside surface of the sponge is demonstrated in U.S. Pat. No. 4,393,871. A slight pull upon the string or loop can cause a single string shown in U.S. Pat. Nos. 4,186,742 and 4,309,997 to pull through the body, can cause a loop shown in U.S. Pat. No. 4,393,871 to pull from the body's outer surface, or a knot and surrounding small portion of the body shown in U.S. Pat. No. 4,693,705 to dislodge from the body. It is necessary to note, that a future source of infection may arise if any portion of the sponge material is allowed to remain in the body cavity for an extended period of time. Moreover, "Toxic shock syndrome", may arise in instances where an infective site is allowed to remain within a body cavity, such as the vaginal canal, for an extended period of time.
A properly inserted and removed sponge or device, not only enhances the benefits of the device, but also maintains long-term effect while positioned. Ease of positioning or insertion is equally important as maintaining the sponge's integrity during removal. A sponge, having a doughnut or flattened shape as shown in U.S. Pat. No. 4,393,871 may easily fold thereby failing to present equal radial pressure against the cavity wall. A passage may therefore be formed in those areas devoid of pressure as a result of the fold.
As defined herein, "spermicide" is a chemical placed in solution, and which provides a chemical barrier against sperm and organisms responsible for STDs. Therefore, "spermicides" used herein include an anti-infective agent.
Spermicides have, in many instances, been found to be active against herpes, gonorrhea, syphilis, trichoinonas, candida, and even HIV. Popular spermicides include benzalkonium chloride, chlorhexidine, gluconate, menfegol, octoxynol and nonoxynol-9. Nonoxynol-9 is a spermicide which acts by destroying the cell wall of the sperm, and is believed to act in the same manner on bacteria and viruses.
As defined herein, "sponge device" refers to any porous device which can be inserted into a physiological cavity. The sponge device includes any porous substance which is capable of being impregnated and/or coated. The sponge device is capable of being placed to a body cavity of a human female. The sponge device can be used to coat the cavity with hormones, amino acids, anti oxidants, lubricants, etc. Further, the sponge device can receive solutions which will reduce or prevent unwanted pregnancies, transfer of disease, growth of a virus fungus, etc. Certainly, the term "device" would include a sponge normally used for insertion into the vaginal canal of a human female.